UnknownNot Applicable

Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

China28 participantsStarted 2022-10-26

Plain-language summary

A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects aged ≥ 18 years.
✓. Subjects with perforated coronary or aortic-coronary bypass graft vessels.
✓. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
✓. The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
✓. Reference vessel diameter from 2.5 mm to 4.0 mm.
✓. According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
✓. Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.

✕. Subjects who are unable to receive anticoagulation or antiplatelet therapy.
✕. Subjects who are unable to tolerate 6 months of DAPT treatment.
✕. Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
✕. According to the judgment of the investigator, subjects who are poorly compliant and unable to complete the study as required; or subjects who are otherwise deemed unsuitable for the enrollment.
✕. Primary or secondary cryptogenic coronary perforation or bleeding.
✕. Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.
✕. anatomical structures proximal to the target lesion or within the lesion (e.g., severe tortuosity, etc.) that would obstruct delivery of the coronary covered stent.
✕. implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.

Procedural Success

Timeframe: During hospitalization (up to 7 days after procedure)

NCT IDNCT05398991

SponsorShanghai MicroPort Rhythm MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07

Ruifen Cao, M.M.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects aged ≥ 18 years.
✓. Subjects with perforated coronary or aortic-coronary bypass graft vessels.
✓. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
✓. The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
✓. Reference vessel diameter from 2.5 mm to 4.0 mm.
✓. According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
✓. Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.

✕. Subjects who are unable to receive anticoagulation or antiplatelet therapy.
✕. Subjects who are unable to tolerate 6 months of DAPT treatment.
✕. Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
✕. According to the judgment of the investigator, subjects who are poorly compliant and unable to complete the study as required; or subjects who are otherwise deemed unsuitable for the enrollment.
✕. Primary or secondary cryptogenic coronary perforation or bleeding.
✕. Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.
✕. anatomical structures proximal to the target lesion or within the lesion (e.g., severe tortuosity, etc.) that would obstruct delivery of the coronary covered stent.
✕. implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.